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Roche shows its Spirit

This article was originally published in The Gray Sheet

Executive Summary

Firm launches its Accu-Chek Spirit diabetes self-management system in the U.S. Oct. 10 following a lift of FDA's import ban on Roche insulin pumps. The hold - in effect since pump maker Disetronic Medical Systems, purchased by Roche in May 2003, received an FDA warning letter in June 2003 - was lifted Oct. 9 following inspection of the Swiss manufacturing site last year (1"The Gray Sheet" July 21, 2003, p. 7). Accu-Chek Spirit, cleared by FDA in 2005, is compact and can be programmed discreetly, the company says. The insulin pump already is sold in 30 countries. Roche is one of a number of firms striving to reach the U.S. market with continuous glucose monitoring technology, where it would compete with Medtronic's Paradigm and Guardian offerings and DexCom's STS system...

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